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Tuesday, March 10, 2026

Mineralys Therapeutics NDA for hypertension drug lorundrostat accepted by FDA

 

 with PDUFA date of December 22, 2026

  • Topline Phase 2 Explore-OSA trial of lorundrostat showed no benefit on apnea-hypopnea index (AHI) endpoint.
  • Despite lack of AHI improvement, lorundrostat achieved clinically meaningful blood pressure reductions with favorable safety profile in Explore-OSA.\
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